Kornimate/medical-research-clean huggingface dataset:
prospective randomized feasibility study comparing manual vs. automatic position-adaptive spinal cord stimulation with surgical leads

Conditions: Chronic Refractory Low Back and Leg Pain

Summary: the main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.

a single-center, prospective, randomized study with a two-arm crossover design. the primary objective of this study is to establish threshold and therapeutic stimulation parameters for the restoresensor neurostimulator in response to postural changes. the secondary objective is to compare the effectiveness of spinal cord stimulation with manual versus automatic position-adaptive settings for chronic refractory low back and/or extremity pain.

Eligibility criteria:
inclusion criteria: * skeletally mature adults between 18 and 70 years old * patients with chronic refractory back and/or leg pain associated with failed back surgery syndrome, post-laminectomy pain, radicular pain syndrome or radiculopathy refractory to conservative and surgical interventions * \> 50% pain reduction during the trail period * willing and able to comply with the requirements of the protocol including follow-up requirements * willing to sign a study specific informed consent exclusion criteria: * previous scs treatment * surgically remediable spinal condition * active local or systemic infection
histological differentiation grade predicted by ultrasound backscatterer imaging

Conditions: Neoplastic Disease; Pathology

Summary: histological grade of hepatocellular carcinoma (hcc) is an important prognostic factor affecting patient survival. it has been divided into four grades from i to iv on the basis of histological differentiation. grade i is the best differentiated consisting of small tumor cells arranged in thin trabeculae. cells with higher grade are larger and less differentiated with hyperchromatic nuclei and loss of trabecular pattern. ultrasound is an imaging modality frequently used to evaluate liver tumors because of its convenience, real-time, less expensive and no radiation exposure. however, ultrasonographic evaluation by conventional b-mode image is semi quantitative and subjective. it still cannot replace liver biopsy for the evaluation of hcc. this study is aimed to quantify the image characters of b-mode image and the scatterer properties using nakagami distribution. nakagami parameter is a general model to describe the distribution of scatterers. therefore, the investigators hypothesized that nakagami parameter may also reflect the histological changes in different grades of hcc. in this study, the resected hcc tumor samples will be collected from the participants who are going to receive surgical resection, and the tumor us images and nakagami values will be obtained via the single-element ultrasound system. the correlation between the ultrasound backscatter parameter and the differentiation grade will be analyzed.


Eligibility criteria:
inclusion criteria: * age 21 to 75 * patients with hcc who underwent surgery * the resected tumor was measured larger than 3 cm exclusion criteria: * patients who have received other treatment in 6 months * patients who couldn't regular follow-up

Keywords: hepatocellular carcinoma(hcc) ultrasound backscatter differentiation grade survival
cohort of antithrombotic use and clinical outcomes in patients with atrial fibrillation (cool-af) phase 2

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is a leading cause of cardiovascular mortality and morbidity. asian patients with af have a higher rate of major bleeding including intracranial hemorrhage (ich) compared to non-asians. non-vitamin k antagonist oral anticoagulants (noacs) are the safer drugs compared to warfarin due to a lower rate of ich, but the rate of noacs use in many asian af is much lower than non-asian countries due to economic concerns. the purpose of the cohort of antithrombotic use and clinical outcomes in patients with atrial fibrillation (cool-af) phase 2 registry is to determine the changes in antithrombotic patterns and the impact on clinical outcomes. the cool-af phase 2 study is a prospective observational multicenter study of patients with known or newly diagnosed non-valvular af in thailand. the aim is a sample size is 3680 patients from 33 centers within a 2-years enrollment timeline. patients will be follow-up every 6 months until 3 years. the study outcomes were death, ischemic stroke/systemic embolism, major bleeding, myocardial infarction, heart failure, and quality of life.


Eligibility criteria:
inclusion criteria: * participants aged 18 years and older with atrial fibrillation diagnosed based on a 12-lead ecg or ecg tracing from ambulatory ecg monitoring. exclusion criteria: 1. patients who have experienced an ischemic stroke within the past 3 months before enrollment. 2. patients with a platelet count less than 100,000/mm3 or who have myeloproliferative disorders (essential thrombocythemia, chronic myeloid leukemia, polycythemia vera, agnogenic myeloid metaplasia), hyperviscosity syndrome, chronic disseminated intravascular coagulation (dic), or antiphospholipid syndrome. 3. patients with a mechanical prosthetic heart valve. 4. patients with rheumatic mitral stenosis. 5. patients participating in research projects with concealed treatments. 6. patients expected to have a life expectancy of less than 3 years due to other diseases, such as cancer or aids, as determined from medical records. 7. pregnancy. 8. patients unable to follow the treatment plan. 9. patients who do not consent to participate in the study. 10. patients who are hospitalized or discharged from the hospital within the past 1 month.contact/locations

Keywords: atrial fibrillation ischemic stroke major bleeding death oral anticoagulant
pilot study of prx-03140 to assess safety for use in adult subjects with post traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this is a clinical study for adult subjects with post traumatic stress disorder.

open label clinical study to evaluate the efficacy of prx-03140 in reducing ptsd symptoms

Eligibility criteria:
inclusion criteria: 1. male and female subjects between ages 18-55 2. the subject has signed and dated the written informed consent to participate in the study 3. the subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions 4. the subject meets criteria for ptsd as defined by the dsm-iv-tr 5. stable use of clinically prescribed medications 6. subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation 7. female subjects - not surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (iud), or vasectomized partner (6 months minimum since vasectomy). exclusion criteria: 1. actively alcohol or drug dependent as defined by dsm-iv-tr criteria 2. patient actively suicidal within last 12-months or with current suicidal ideation 3. history of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview 4. participation in a clinical drug research study within the past 30 days 5. subject currently taking any ssri or anti-depressant medication. 6. pregnant or breastfeeding females 7. subjects will be excluded based on lab values, ecg findings, or physical findings that the investigators deems exclusionary.

Keywords: ptsd post traumatic stress disorder
resveratrol in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.

osteoarthritis (oa) is the first cause of handicap in individuals over 40 years-old in france. oa physiopathology is driven in part by local joint inflammation responsible for pain and joint destruction. experimental studies have shown that resveratrol, a molecule antagonist to the aryl hydrocarbon receptor, has anti-inflammatory and chondroprotective properties in vitro and in vivo. the investigators hypothesize that oral resveratrol, in a new formulation improving its bioavailability, could reduce knee pain at 3 months as compared with placebo in people with knee oa.

Eligibility criteria:
inclusion criteria: * age ≥ 40 years-old * knee osteoarthritis fulfilling 1986 american college of rheumatology (acr) criteria * pain on numeric rating scale ≥ 40/100 * symptom duration ≥ 1 month * kellgren and lawrence x-ray score 1, 2 or 3 * written consent obtained * health insurance cover exclusion criteria: * history of symptomatic crystal or inﬂammatory arthritis * knee surgery ≤ 1 year * knee trauma ≤ 2 months * knee intra-articular injections of corticosteroids and/or hyaluronic acid ≤ 2 months * neurologic disorders involving the lower limbs * patient not understanding and not speaking french * participation in another biomedical research * contraindication to resveratrol or hypersensitivity to any of its constituents * current use of intramuscular, intravenous or oral corticosteroids * uncontrolled diseases that may require intramuscular, intravenous or oral corticosteroids * current use of anticoagulants

Keywords: osteoarthritis knee resveratrol oral treatment pain trial
study of efficacy and safety of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous nsclc subjects

Conditions: Non-small Cell Lung Cancer

Summary: this was a phase iii study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous nsclc participants.

the study primarily assessed the safety and tolerability (safety run-in part a) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab, and then, the efficacy (double-blind, randomized, placebo-controlled part b) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

Eligibility criteria:
key inclusion criteria: * histologically confirmed locally advanced stage iiib or stage iv nsclc for treatment in the first-line setting * known pd-l1 status determined by a novartis designated central laboratory. a newly obtained tissue biopsy or an archival biopsy (block or slides) is required for pd-l1 determination (pd-l1 ihc 22c3 pharmdx assay), prior to study randomization. note: for the safety run-in part, known pd-l1 status is not required. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * at least 1 measurable lesion by recist 1.1 key exclusion criteria: * previous immunotherapy (e.g. anti-pd-1, anti-pd-l1, anti-pd-l2, anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways). * prior treatment with canakinumab or drugs of a similar mechanism of action (il-1β inhibitor). * subjects with epidermal growth factor receptor (egfr) sensitizing mutations (identified in exons 19, 20, or 21), and/or alk rearrangement by locally approved laboratory testing. * previously untreated or symptomatic central nervous system (cns) metastases or lepto-meningeal disease. * subject with suspected or proven immune-compromised state or infections. * subject has prior to starting study drug: received live vaccination ≤3 months, had major surgery ≤4 weeks prior to starting study drug, has thoracic radiotherapy: lung fields ≤ 4 weeks, other anatomic sites ≤ 2 weeks, palliative radiotherapy for bone lesions ≤ 2 weeks.

Keywords: acz885 canakinumab pembrolizumab carboplatin cisplatin paclitaxel nab-paclitaxel pemetrexed nsclc non-small cell lung cancer non small cell lung cancer squamous non-squamous hscrp il-1β pd-l1 canopy canopy-1 platinum-based doublet chemotherapy first line therapy locally advanced metastatic
comparison of fiasp and aspart during postprandial exercise in adults with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: hypoglycemia is the main barrier for physical activity practice of patients with type 1 diabetes (t1d). for postprandial exercise, anticipation with meal insulin bolus reduction is the recommended method to reduce exercise-associated hypoglycemic risk. the impact of faster acting aspart (fiasp) pharmacokinetic on hypoglycemic risk has not yet been explored. this study will explore two different timings for exercise onset. objective: to compare the impact of rapid-acting insulin aspart and faster acting aspart (fiasp) on glucose reduction during exercise. design: this study is a randomized, four-way, crossover study to compare the efficacy of 1) rapid-acting insulin aspart, and 2) fiasp on glucose reduction during an exercise performed 60 minutes or 120 minutes after breakfast. the insulin used and the timing of the exercise will be randomized. this project will be conducted at institut de recherches cliniques de montréal (ircm, montreal, canada). hypothesis: faster acting aspart (fiasp) will be non-inferior to insulin aspart for hypoglycemic risk.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years of old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. hba1c ≤ 9.5%. 4. patients using multiple daily injections with basal-bolus insulin regimen and insulin analogs (pre-meal: aspart, lispro, guilisine or fiasp; basal: detemir, glargine u100 \& u300, degludec u100). 5. written informed consent given. exclusion criteria: 1. clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. 2. recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 3. anemia (hb \< 100g/l). 4. ongoing pregnancy or breastfeeding. 5. severe hypoglycemic episode within two weeks of screening. 6. other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation). 7. ongoing treatment with csii (continuous subcutaneous insulin infusion) "insulin pump therapy". 8. participation to a clinical trial in the last 3 months prior to inclusion in this study.
4 versus 6 cm active phase of labour

Conditions: Labor Complication; Cervix; Open

Summary: a study to compare maternal and perinatal outcome between 4 and 6 cm cervical dilatation at amniotomy.

low risk women with singleton pregnancy are recruited. there are two groups which are 4 and 6 cm cervical os dilatation. the intrapartum management and labour outcomes are documented.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * no medical disorders * no antenatal complications such as hypertension and diabetes exclusion criteria: * fetal anomaly * one previous caesarean section * other uterine scars

Keywords: active labour 4 and 6 cm low risk women
efficacy of tachosil as dural sealant compared to standard treatment

Conditions: Subjects Scheduled for Supra-/Infratentorial Craniotomy

Summary: main objective of this trial is to assess the hypothesis whether the application of tachosil® as a dural sealant improves the quality of craniotomy procedure and outcome in general compared with standard dural closure techniques in a controlled and randomized way. as a primary endpoint the investigators look at possible postoperative occurrence of csf pads or leakages needing any kind of intervention until day 30 after the primary craniotomy. furthermore, the investigators will look at other surgery-related complications and at pharmacoeconomic endpoints such as hospital stay or cost of the implant. overall, the results of this study will provide important information on whether or not the adjunct of a relatively expensive implant on a routinely basis for the closure of elective craniotomies is safe and effective, or not. to date, tachosil® is often used in neurosurgery and other surgical disciplines in a non-standardized fashion also to prevent csf leakage after dural closure. so far, adverse events directly related to the product have not been reported. theoretically, any implant may be associated with a higher incidence of postoperative infections (e.g. epidural, subdural or subgaleal empyema). on the other hand, it is not known whether or not the application of tachosil® on the dural suture may reduce csf leakage.


Eligibility criteria:
inclusion criteria: * neurosurgical indication for craniotomy and opening of dura to access cerebral structures/pathologies (discussed in the indication conference of board certified neurosurgeons at the university hospital of basel). * the list of pathologies includes: * primary or secondary benign/malignant brain tumors * aneurysms * arterious-venous malformations * cavernomas * pituitary adenomas * temporal lobectomy (epilepsy surgery) * longterm posttraumatic revisions. exclusion criteria: * presence of subdural empyema/abscess or any kind of infection affecting/infiltrating the dura mater * emergency for trauma * previous surgery on the same site * cases, where water-tight dural suture is not possible (intraoperative exclusion decision) * known hypersensitivity to tachosil® * participation in another study * pregnancy * inability to read and understand the participant's information

Keywords: craniotomy outcome csf leakage dural sealant
a research study to test safety, tolerability, and immunogenicity of a recombinant hepatitis b vaccine manufactured with an upgrade to the production process (v232-054)

Conditions: Hepatitis B Infection

Summary: a study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis b vaccine manufactured using an upgrade to the production process. the primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis b surface antigen (hbsag), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to hbsag, and 3) the process upgrade vaccine will induce geometric mean antibody titers to hbsag that are non-inferior or superior to those induced by the current process vaccine.


Eligibility criteria:
inclusion criteria: * in general good health * female participants have a negative pregnancy test just prior to vaccination on day 1 exclusion criteria: * history of hepatitis b infection or vaccination * known or suspected hypersensitivity to any component of recombivax hb™ vaccine (e.g., aluminum, yeast) * administration of hepatitis b immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on day 1 * receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on day 1 * participation on prior study using an investigational drug or vaccine in prior 3 months * known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids * pregnant or nursing women or women planning to become pregnant within the study period
cultural adaptation, validity, and reliability of the turkish version of north star ambulatory assessment

Conditions: Duchenne Muscular Dystrophy; Ambulation Difficulty; Ambulation Disorder, Neurologic

Summary: the aim of this study is to translate the "north star ambulatory assessment (nsaa)" scale into turkish and make its cultural adaptation and to demonstrate the reliability and validity of the turkish version in patients with ambulatory dmd. for the translation into turkish, validity and reliability of the nsaa, necessary permission was obtained from the developer of the questionnaire, prof. dr. francesco muntoni, via e-mail. in the study, first of all, the translation and cultural adaptation process will be completed, and then reliability-validity studies will be carried out.


Eligibility criteria:
inclusion criteria: * being diagnosed with dmd * ambulatory * being between the ages of 4-18 * agreeing to participate in the research voluntarily exclusion criteria: * insufficient cooperation with the physiotherapist, * have had any injury and/or surgery of the lower extremities in the last 6 months, * having neurological problems in addition to dmd. -

Keywords: duchenne muscular dystrophy ambulation reliability validity
comparison of two pain-treatment techniques after tympanomastoid surgery pain

Conditions: Pain Management; Nerve Block; Ultrasound

Summary: analgesia following tympanomastoid surgery is critical for the prevention of postoperative . there are very few regional anesthesia methods used to achieve this goal.

in this study, it was aimed to investigate the effect of ultrasound guided superficial cervical plexus block versus greater auricular nerve block for on postoperative tympanomastoid surgery analgesia.

Eligibility criteria:
inclusion criteria: * patients who were in the american society of anesthesiologists (asa) i-iii class and underwent tympanomastoid surgery. exclusion criteria: * previous history of opioid use preoperatively, * allergy to local anesthetics, * the presence of any systemic infection, * uncontrolled arterial hypertension, * uncontrolled diabetes mellitus.
short-course preoperative chemoradiotherapy for rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of krog 11-02.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma 2. distal margin of the tumor located \< 8 cm above the anal verge 3. ct3-4 or cn+ classification as determined by endorectal ultrasonography (eus) and ct 4. patient older than age 18 years 5. karnofsky performance score \>= 70 exclusion criteria: 1. distant metastasis identified during staging workup 2. previous or concurrent malignancy 3. pregnant or breast-feeding women 4. impending rectal obstruction 5. familial adenomatous polyposis

Keywords: locally advanced rectal cancer